Thermo Fisher Scientific QC IA, QC Engineer/Scientist I in Fremont, California
Performs routine testing of bulks, components and finished kits according to established quality control procedures using different instrument platforms.
Documents test results, complete batch records, document problems and other relevant information under cGMPs.
Maintains and analyze lot histories for trends and discrepancies.
Performs initial review on departmental paperwork; completed batch records
Performs initial troubleshooting of issues which arise during routine analysis, perform out of specification (OOS investigations) and if needed, initiate non-conformance (NCAR) reports.
Initiates OOS, NCARs and Variances, as required.
Performs initial troubleshooting of issues which arise during routine analysis under the direction of the Supervisor and Technical Operations.
Documents test results, problems and other relevant information under cGMPs.
Performs simple procedure and worksheet revisions, as necessary.
Participates in departmental meetings.
Maintain laboratory space and participate in lab clean ups
Performs other responsibilities to support the needs of the department, as assigned by Supervisor.
Keeps department lead or supervisors updated on all issues.
Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred.
High level of reading comprehension and verbal communication skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear, understandable documentation.
Manual dexterity must be able to lift/move up to 20 pounds.
Must be detail oriented and perform the work at a consistent level.
Intermediate word processing and spreadsheet software skills.
Strong organizational skills to be able to manage priorities and multiple tasks simultaneously.
Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
Working knowledge of clinical analyzers is a plus.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.